Efficacy of Cryoablation of Abdominal Wall Endometriosis

NCT ID: NCT03627676

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-08
• Study Completion Date: 2020-10-31

Brief Summary

The aim of this study is to evaluate for the first time prospectively the efficacy on the symptoms and the tolerance of percutaneous cryoablation performed under radiological guidance of endometriosis of the abdominal wall in alternative to surgery after validation in multidisciplinary meeting.

Detailed Description

Design of the study :

Non-comparative, non-randomized monocentric phase II trial designed as a two-staged Simon minimax plan.

Inclusions will be suspended at the end of the first stage. Statistical stopping rules are detailed in the justification of the number of patients required.

Inclusion: Patients will be included after validation in multidisciplinary consultation by the interventional radiologist in charge of the patient.

Follow-up: Only the cryoablation procedure is performed as an alternative to surgery, the usual follow-up of these patients will be maintained (1 consultation / 3 months, 1 MRI every 6 months). Additional consultations on D7 and M1 will be conducted by phone (symptoms and pain history only).

Device(s) under investigation The Endocare® Cryocare® Systems consist of a compact, easy-to-operate console and associated accessories that include Endocare® cryoprobes to deliver cold temperatures to the therapeutic tissue and Endocare® TempProbe® devices to monitor temperatures in the surrounding tissue. The Cryocare® Systems are intended for use in open, minimally invasive procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, proctology, pulmonary surgery and thoracic surgery.

The systems are designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

CE Mark; Classe IIa

Expected benefits for the participants and for society This study has a direct individual benefit because of the proposed curative treatment by cryoablation as an alternative to other therapeutic modalities. For the society, the minimally invasive cryoablation may reduce the hospitalization stay and the complication's rate compare to the reference standard (surgery).

Conditions

Nodule; Endometriosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Cryoablation

Intervention Type: PROCEDURE

Two percutaneous cryoprobes would be used for all patients. The 17-Gauge cryoprobes is introduced into the masses under US guidance. Mean distance to the skin has to be 5mm at least. Although US guidance is used, a non-enhanced CT scan may be used to assess the position of the cryoprobes before ablation, and to obtain a baseline examination in order to avoid thermal injuries to adjacent tissues such as the bowel during the ice growth. No ice extension to the skin has to be observed during cycles assessed by real-time US monitoring. Each cryoablation procedure involves 3 successive cycles: 10 minutes freeze with Argon gas, followed by 9 minutes passive and 1 minute active thawing with Helium gas, followed by a second 7 minutes freeze. The ice covered the entire targeted lesion on the short axes is visualize by US or CT-scan performed at the end of the three cycles or after repositioning. At the end of the cryoablation procedures, the probes are removed through active thawing.

Interventions

Cryoablation

Two percutaneous cryoprobes would be used for all patients. The 17-Gauge cryoprobes is introduced into the masses under US guidance. Mean distance to the skin has to be 5mm at least. Although US guidance is used, a non-enhanced CT scan may be used to assess the position of the cryoprobes before ablation, and to obtain a baseline examination in order to avoid thermal injuries to adjacent tissues such as the bowel during the ice growth. No ice extension to the skin has to be observed during cycles assessed by real-time US monitoring. Each cryoablation procedure involves 3 successive cycles: 10 minutes freeze with Argon gas, followed by 9 minutes passive and 1 minute active thawing with Helium gas, followed by a second 7 minutes freeze. The ice covered the entire targeted lesion on the short axes is visualize by US or CT-scan performed at the end of the three cycles or after repositioning. At the end of the cryoablation procedures, the probes are removed through active thawing.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient ≥18 years,
• Initial radiological diagnosis of endometriosis of the abdominal wall, radiologically proven by MRI (or Doppler-ultrasound or CT-scan) with or without contrast injection,
• Symptomatic nodule (pain),
• Patient in at least one of the following situations:

• Failure of previous treatments: recurrence of symptoms (pain) after medical therapies following the Haute Autorité de Santé (HAS) recommendations and / or prior surgery,
• Or first-line or second-line medical therapies following the HAS recommendations considered as potentially non effective locally in multidisciplinary consultation meeting, or contraindicated or refused by patient,
• Or surgery considered as potentially non effective locally or as a potential cause of adverse effects and morbidity because too devastating, in multidisciplinary consultation meeting,
• Cryoablation technically feasible after discussion in multidisciplinary consultation meeting:

• localization at a distance of 5 mm from the skin (risk of skin lesion if the ice ball is at less than 5 mm from the skin) and from major nervous structures (risk of sideration),
• 3 nodules maximum
• nodule size up to 5 cm (<5 cm) in the largest diameter
• Absence of contraindications to general anesthesia if applicable,
• Effective contraception during participation in the study.
• Informed consent signed,
• Patient affiliated to a social security.

Exclusion Criteria

• Pregnant woman,
• Uncontrolled coagulation disorders (TP <50%, TCA> 1.5x control) or anticoagulant therapy (blood sample prescribed at the inclusion and results verified at D0),
• Abnormalities of the hemogram: platelets <90000/mm3 (blood sample prescribed at the inclusion and results verified at D0),
• Documented infectious disease,
• Patient included in another interventional study,
• Impossibility to submit to the medical follow-up for geographical, social or psychological reasons,
• Patients deprived of liberty or subject to a legal protection measure or unable to express their consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Cornelis, Professor

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Radiology Department

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

François Cornelis, Professor

Role: CONTACT

francois.cornelis@aphp.fr

+33 1 56 01 68 87

Facility Contacts

François Cornelis, Professor

Role: primary

francois.cornelis@aphp.fr

+33 1 56 01 68 87

Other Identifiers

2017-A02409-44

Identifier Type: OTHER

Identifier Source: secondary_id

P160802J

Identifier Type: -

Identifier Source: org_study_id